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Completed
NCT07622355
Effects of Different Administration Routes of Dexmedetomidine on Postoperative Sleep Quality in Patients Undergoing Thyroidectomy
Conditions: Thyroid Diseases
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: PHASE1, PHASE2
Enrollment: 120
Sponsor: The Second People's Hospital of Huai'an
Location: The Affiliated Huaian Hospital of Xuzhou Medical University, Huai'an Second Hospital, Huaian Huai'an
Summary
Patients undergoing thyroid surgery often experience significant preoperative anxiety and show high concern about voice changes, scar formation and other related issues. Postoperative neck discomfort and dysphagia also tend to disrupt normal sleep. Dexmedetomidine activates α₂ receptors in the mesencephalic-pontine-medullary reticular formation, inhibits the release of norepinephrine, and induces a sleep state similar to non-rapid eye movement (NREM) sleep, particularly the N2 stage, which is closer to physiological sleep. This study aimed to explore the effects of intranasal spray versus intravenous administration of dexmedetomidine on postoperative sleep quality in patients undergoing thyroidectomy. By optimizing preoperative pharmacological intervention, it intends to improve patients' postoperative sleep quality, relieve pain and reduce postoperative adverse reactions, enhance recovery quality, and optimize patients' satisfaction and comfort level.
Eligibility Criteria
Inclusion Criteria:
* Age: 18-65 years old
* ASA classification: Grade I or II
* BMI: 18-30 kg/m²
* Planned to undergo thyroid benign tumor or thyroid malignant tumor resection under general anesthesia
* No history of sedatives or sleeping pills used within 1 week before surgery
* Agree to participate in the study and sign the informed consent form
Exclusion Criteria:
* History of sleep disorders or mental illness
* Use of sleep-affecting drugs such as antidepressants and sleeping pills
* Allergy to dexmedetomidine and other drugs
* Patients with nasal lesions or intolerance to nasal sprays
* Cardiac conduction block, severe bradycardia or hypotension
* Pregnant or lactating women
* Patients with severe dysfunction of the heart, brain, lungs, liver, kidneys or other organs
* Patients with difficult airway during anesthesia induction who need to change the conventional intubation method
* Patients who refuse to participate in this study and do not sign the informed consent form
Source: ClinicalTrials.gov (NCT07622355). StuddyBuddy aggregates publicly available trial information.